COLLAGEN BONE HEALING PROTECTIVE SHEET

K052041 · Collagen Matrix, Inc. · HRS · Oct 25, 2005 · Orthopedic

Device Facts

• Record ID: K052041
• Device Name: COLLAGEN BONE HEALING PROTECTIVE SHEET
• Applicant: Collagen Matrix, Inc.
• Product Code: HRS · Orthopedic
• Decision Date: Oct 25, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Collagen Bone Healing Protective Sheet is intended to maintain the relative position of weak bony tissue such as bone grafts, bone graft substitutes, or bone fragments from comminuted fractures. The Collagen Bone Healing Protective Sheet is also indicated for cement restriction in total joint arthroplasty procedures. Only when used in conjunction with traditional rigid fixation, the Collagen Bone Healing Protective Sheet is intended to maintain the relative position of weak bony tissue in trauma and reconstructive orthopedic procedures involving: Long bones . Flat bones . Short bones . Irregular bones . Appendicular skeleton . Thorax . When used alone (without traditional rigid fixation), the Collagen Bone Healing Protective Sheet is intended to maintain the relative position of bone grafts or bone graft substitutes in reconstructive orthopedic procedures involving: Tumor resections where bone strength has not been compromised . Iliac crest harvests . This device is not intended for use in the spine. The device is not intended for load bearing indications unless used in conjunction with traditional rigid fixation.

Device Story

Collagen Bone Healing Protective Sheet is a resorbable, conformable membrane matrix derived from bovine Achilles tendon type I collagen. Device is supplied as a sterile, non-pyrogenic sheet (0.5-2.0 mm thick) with micropores (<0.008 um) and optional macropores (500 um). Used by surgeons in orthopedic procedures to contain bone grafts, graft substitutes, or bone fragments. Can be cut, rolled, or shaped to fit anatomical sites. Functions as a physical barrier to maintain tissue position; used alone or with internal fixation (plates/screws). Benefits include stabilization of graft material and restriction of cement in arthroplasty. Not for load-bearing or spinal use.

Clinical Evidence

No clinical trials performed. Safety and efficacy supported by biocompatibility testing per ISO 10993-1 and review of animal and clinical literature regarding the use of collagen membranes for bone graft containment.

Technological Characteristics

Material: Highly purified type I collagen from bovine Achilles tendon. Form: Conformable, resorbable membrane. Dimensions: 20x20 mm to 120x120 mm; 0.5-2.0 mm thickness. Porosity: Micropores <0.008 um, optional macropores 500 um. Sterilization: Sterile, non-pyrogenic. Single-use.

Indications for Use

Indicated for patients requiring maintenance of bone graft, bone graft substitute, or bone fragment position in trauma, reconstructive orthopedic procedures, or total joint arthroplasty. Contraindicated for use in the spine and for load-bearing applications unless used with rigid fixation.

Regulatory Classification

Identification

Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.

Predicate Devices

• Collagen Dental Membrane (K011695)
• BioGide® (K960724)
• EBI LactoSorb® Graft Containment System (K033918)
• MacroPoreOS Protective Sheet (K994158)

Submission Summary (Full Text)

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K052041

Dean Lab

# 0C1 25 2005

### 510(k) Summary of Safety and Effectiveness

| Applicant Name and Address: | Collagen Matrix, Inc.<br>509 Commerce Street<br>Franklin Lakes, New Jersey 07417 | | |
|-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------|-------------------------------------------------|
| Contact Person: | Peggy Hansen, RAC<br>Director, Clinical, Regulatory, and Quality Assurance<br>Tel: [phone]<br>Fax: [phone] | | |
| Date of Summary: | October 25, 2005 | | |
| Device Common Name: | Collagen Bone Healing Protective Sheet | | |
| Device Trade Name: | To be determined | | |
| Device Classification Name: | Plate, Fixation, Bone<br>Class II<br>888.3030<br>HRS | Mesh, Surgical<br>Class II<br>878.3300<br>FTM | Cement Obturator<br>Class II<br>878.3300<br>LZN |
| Predicate Device(s): | Collagen Dental Membrane, K011695<br>BioGide®, K960724<br>EBI LactoSorb® Graft Containment System, K033918<br>MacroPoreOS Protective Sheet, K994158 | | |

#### Description of the Device

The Collagen Bone Healing Protective Sheet is a white, nonfriable, conformable, resorbable, membrane matrix engineered from highly purified type I collagen derived from bovine Achilles tendon. The Collagen Bone Healing Protective Sheet can be cut with scissors to the desired shape and size. The Collagen Bone Healing Protective Sheet is fully conformable when hydrated and can conform three dimensionally to most any anatomical orientation. The Collagen Bone Healing Protective Sheet can be rolled into a tube or used as a flat sheet. The Collagen Bone Healing Protective Sheet can be used cither alone or in conjunction with internal bonc fixation devices such as plates and screws, which also can scrve to further stabilize the anatomical region.

The Collagen Bone Healing Protective Sheet is provided in sheets of 20 x 20 mm to 120 x 120 mm and will be provided in other sizes as needed for particular surgical procedures. The thickness of the Collagen Bone Healing Protective Shect ranges from 0.5 mm to 2.0 mm according to the orthopedic region to be treated. The Collagen Bone Healing Protective Sheet consists of micropores <0.008 um and is provided with or without the addition of macropores in the range of 500 um. Collagen Bone

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Haskell
Page 2 of 2

Healing Protective Shect is supplied sterile, non-pyrogenic, in various sizes, and for single use only.

#### Intended Use

The Collagen Bone Healing Protective Sheet is intended to maintain the relative position of weak bony tissue such as bone grafts, bone graft substitutes, or bone fragments from comminuted fractures. The Collagen Bone Healing Protective Sheet is also indicated for cement restriction in total joint arthroplasty procedures.

Only when used in conjunction with traditional rigid fixation, the Collagen Bone Healing Protective Sheet is intended to maintain the relative position of weak bony tissue in trauma and reconstructive orthopedic procedures involving:

- Long bones .
- Flat bones �
- Short bones .
- Irregular bones .
- Appendicular skeleton .
- Thorax .

When used alone (without traditional rigid fixation), the Collagen Bone Healing Protective Sheet is intended to maintain the relative position of bone grafts or bone graft substitutes in reconstructive orthopedic procedures involving:

- Tumor resections where bone strength has not been compromised .
- Iliac crest harvests .

This device is not intended for use in the spine. The device is not intended for load bearing indications unless used in conjunction with traditional rigid fixation.

### Summary/Comparison of Technical Characteristics

The indication for use of the Collagen Bone Healing Protective Sheet is the same as that of its predicate devices. The technical charactcristics of the Collagen Bone Healing Protective Sheet are comparable to the predicate devices in key aspects of the device such as material, form, sizes, thickness, physical integrity, mechanical strength, porosity and in vivo stability. The animal and clinical literature reviews provide compelling support for the use of the Collagen Bone Healing Protective Sheet in containing bone graft material and bonv fragments in bone defects.

### Safety

The safety/biocompatibility of the Collagen Bone Healing Protective Sheet is supported by the biocompatibility testing performed in accordance with FDA's Blue Book Memorandum G95-1 and ISO 10993-1 Biological Evaluation of Medical Device.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The caduceus is depicted as a stylized design with three lines forming the shape of a bird or wing. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" is arranged in a circular pattern around the caduceus.

Public Health Service

OCT 2 5 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Peggy Hansen, RAC Director, Clinical, Regulatory & Quality Assurance Collagen Matrix, Inc. 509 Commerce Street Franklin Lakes, New Jersey 07417

Re: K052041

Trade/Device Name: Collagen Bone Healing Protective Sheet Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HRS, FTM, LZN Dated: July 27, 2005 Received: July 29, 2005

Dear Ms. Hansen:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA is issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2- Peggy Hansen, RAC

This letter will allow you to begin marketing your device as described in your Section 510(k) This leter will and in yours of substantial equivalence of your device to a legally prematics notification. The a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you dealer specific darioliance at (240) 276- 0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general miorination on Joan Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Mark N. Melkerson
Acting Director

Acting Director Division of General, Restorative, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

| 510(k) Number (if known): | K052041 |
|---------------------------|---------|
|---------------------------|---------|

Collagen Bone Healing Protective Sheet Device Name:

Indications for Use:

The Collagen Bone Healing Protective Sheet is intended to maintain the relative position rfic Ookugon Bone Houne grafts, bone graft substitutes, or bone fragments from or would bony «coures. The Collagen Bone Healing Protective Sheet is also indicated for cement restriction in total joint arthroplasty procedures.

Only when used in conjunction with traditional rigid fixation, the Collagen Bone Healing Protective Sheet is intended to maintain the relative position of weak bony tissue in trauma and reconstructive orthopedic procedures involving:

- Long bones .
- Flat bones t
- Short bones �
- Irreqular bones .
- Appendicular skeleton �
- Thorax .

When used alone (without traditional rigid fixation), the Collagen Bone Healing Protective Sheet is intended to maintain the relative position of bone graft substitutes in reconstructive orthopedic procedures involving:

- Tumor resections where bone strength has not been compromised .
- . lliac crest harvests

This device is not intended for use in the spine. The device is not intended for load bearing indications unless used in conjunction with traditional rigid fixation.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use _ (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

200

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

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510(k) Number_ LO 5 2041